General News. Product Notes

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1 TO: HELENA POC DISTRIBUTORS FROM: HELENA POINT OF CARE SUBJECT: ROUND-UP/INTERNATIONAL DATE: 8/31/2009 ATTN: ROUNDUP READERS CLINICAL TRIAL SITES NEEDED! As Helena POC continues development of Cascade POC applications, we need clinical trial sites for the generation of data so that the test systems may get FDA/EU approval. We are currently looking for sites that are using the Direct Thrombin Inhibitors (DTI s) Refludan (leprudin (rdna)) and Argatroban. We are asking that if you have in your territory institutions using these DTI s that may be willing to participate in such a trial, would you please notify Richard Rullman, Helena s clinical trials coordinator,with the contact information. His address is rrullman@helena.com.we appreciate your efforts and look forward to continuing delivery of new and innovative quality healthcare products. General News We have concluded a very large meeting with the AACC in Chicago. The leads have been processed and information has been mailed to your accounts and copies of the leads are being sent to you. The majority of the leads generated for POC were based on the Cascade POC. The activity in the POC booth centered on Plateletworks (13 leads), Cascade POC (19 leads) and ACT s (2 leads). On many of the leads were notes indicating needs for immediate calls, demos or further information. With the priority of getting sales quickly we need to respond to these leads. Remember this was a laboratory meeting so many of these customers also saw our competitors. We are shipping instruments and reagents at this time As a reminder our next two meetings will be the Am Assoc of Blood Banks in New Orleans Oct and the Am Society of Anesthesia also in October in New Orleans. We will be showing the Cascade POC, Plateletworks, and Actalyke products at these meetings. This only leaves at little time before the next round of leads are generated so we need to have the last group seen, demoed, and sold quickly. Product Notes We are seeing an increased awareness for monitoring the anti-platelet market. We are attaching the latest in studies with more to be added to the website soon. There are some interest new papers regarding the use of Clopidogrel and Aspirin we will discuss a little later. However, some of the interesting news comes in that the FDA has approved a new Plavix competitor while in Europe they have approved six new generic versions

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49 which one has been in Germany since last August and the will soon be used in the EU. Plateletworks is the system that offers you and your customers an excellent choice with three agonists and an inexpensive instrument..instrument Notice The push on Cascade POC has been going well. However due to some equipment issues our production of test cards has been unable to keep up to the demand. With new equipment now in Beaumont we are beginning to rebuild inventory. It is going to be at least until into October before we are in a more comfortable position. On the positive side we have good inventory of Plateletworks and ACT tubes. We have inventory of the ICHOR II instruments and more on order. There is a very good price structure and these systems can easily be done with RR. We are seeing an increased push both in the labs and from surgery for TEG units. Remember that Plateletworks is faster, easier, less expensive, and is quantitative and qualitative. While those distributors in Europe are not able to order the ICHOR II from Helena due to CE issues we can tell you that MINDRAY has distribution of the BC 3200 CE version in Europe. Several of our Helena POC distributors have made direct contact with MINDRAY or MINDRAY distributors for instruments. MINDRAY will work with you to get the best available pricing and service if you identify yourself as being a Helena POC distributor. What we in Beaumont ask is that if you work with MINDRAY and purchase equipment from them that you keep Helena apprised as to the number of systems acquired. Article Reviews Transfusions Transfusions are a major topic for surgery and trauma units. The attached article from the AABB News starts this section with a description of Massive transfusions and protocols. Besides just the blood loss there is coagulation loss as well and that needs to be considered by the blood bank and monitored by someone. There are guidelines here concerning the use of the PT, aptt, platelet count, hemoglobin, and fibrinogen. While not mentioned specifically here it should be noted that many of these lab (POC) tests should not be run during transfusions as they may well reflect the transfused product status vs. patient status. Note the recommended 1:1:1 ration of RBC to platelet to plasma. The next two refer to transfusions when treating cancers and the emphasis on the age of the samples. There are also two studies here concerning risks when transfusion CABG patients. Look at the increased risks of stroke and death. When talking about Plateletworks and transfusion reduction note the increased costs (indirect) associated with transfusion during or after surgery such as long OR time, return to surgery which in the US is generally non-reimbursable within the first 30 days, and longer hospital stays. Also note the increased infection rates. If you don t have to transfuse then don t. Plateletworks as a POC test can be a very effective triage tool for the physician. A side note from the next article is the possibility of a sever reaction TRALI and why Canada is banning previously pregnant females from being platelet donors at a time when supplies are low anyway. 2

50 Plateletworks ADP Inhibition The first article here comes from Europe with a comparison of Plateletworks with traditional LTA for Plavix monitoring. Plateletworks does a good job and the telling issue is essentially our pitch that because of timing this needs to be done at the POC. Secondly, here is the announcement from Europe of the six generic competitors are being used and considered in Europe. That means at some time they will be in the US and with competition the prices go down and then there are more users. These drugs will need to be monitored. Next is an article concerning Plavix and CABG. This appears to state that patients on Plavix do not need to discontinue Plavix before CABG. Another point we have made here that if the functional count is high enough then they won t bleed excessively. Then a study and more notice of interference with Plavix due to proton pump inhibitors. With this interference another need for monitoring. Another very interest study uses Plavix and Aspirin in diabetic nephropathy patients. Here patient with Plavix showed a higher hazard of cardiovascular and overall mortality events than placebo patients. Question- is the prescription of Plavix and Aspirin a safe treatment? Do prescription drugs need to be monitored? Are you looking at the diabetic (Endocrinology) market for lead follow up? Last but not least the notice from the FDA of the release of Prasurgrel ( Effient) for use in PCI. Note that this may produce higher bleeds than Plavix but that it is an effective competitor to Plavix. Plateletworks and Aspirin A couple of papers concerning Aspirin including a study questioning the routine use of Aspirin in healthy individuals and concerning the use of proton pump inhibitors and Aspirin. The first describes the use of Aspirin on an individual basis with a notation on page 3 concerning drug safety is disease free populations. Who tests for Aspirin effect and whether or not it even works for platelet inhibition when prescribing? The paper on PPI s shows that patients may be at risk for bleeding issues. This also uses the words concerning safety and risks of interaction with Plavix. This is a study showing that a new PPI may be effective in these patients but here also is another interference with a non-prescription issue of infection. Is it safe for just everybody to take Aspirin on a routine basis? Low Molecular Weight Heparin As we go into trials for the CPOC ENOX card testing here are some of the preliminary papers concerning LMWH s and issues. The first describes a use for LMWH and bridging (note this word is being used more frequently by physicians) patients on Oral anticoagulants in preparation for PCI or surgery. Note the concern over safety and this will be a reason for LMWH testing. The next paper is on monitoring LMWH and dosing protocols to avoid excess LMWH and bleeding. In this case they use the aptt and there are concerning over ranges and changes in reagents due to sensitivities. Currently errors occur and we are looking at the CPOC ENOX cards as a better alternative to monitoring. 3

51 The last paper here refers to a practice called stack-on where patients already on LMWH are also given Unfractionated Heparin (UFH)prior to or during procedure and the physician counts on the ACT for results and they are misleading. One of the final comments (recommendations) is that an anti-xa assay be used. Our CPOC ENOX cards are basically an anti Xa assay and are being trialed against anti Xa assays. However the anti-xa assays today are chromogenic and need to be run in the lab and are not suited for POC. Prothrombin Monitoring While we saw the bridging to LMWH in the previous section the next article also refers to bridging but specifically to Warfarin patients. In this case there is an argument for not using LMWH and not discontinuing Warfarin. Here the authors argue that for surgical procedures such as pacemakers and defibrillators patients with high thrombotic risk may safely be kept on the Warfarin. Again the last paragraph may hold the key and that is the physician needs to know what the patient s coagulation status is. Another need for PCOC in Surgery? The next is a complicated topic looking at patients on triple antithrombotic therapy. This means Plavix, Aspirin and Warfarin. Note that there are many patients with multiple diseases who need to be treated. Here concrete recommendations are limited but the issues are there including risks bad enough to require transfusions and increase costs. There are suggestions on the second page concerning doses however of the drugs used, and for patients receiving stents. There are some recommendations concerning bleeding and one of these is to closely maintain the INR at 2.0. The last section of the article discusses new drugs including oral anti-coagulant competitors, new ADP inhibitors, a possible replacement for Aspirin, and new stent technology. The world of Coagulation and anti-coagulation is alive and very active and is an excellent growth market for Helena POC. Stay tuned for new product releases and new lines from Helena Laboratories POC! Good Selling! 4